Atopic Dermatitis
Conditions
Brief summary
• Nemolizumab serum concentrations at Weeks 4, 8, 12, 16, 32, and 52. • Nemolizumab serum PK parameters estimated with a population PK analysis., • Incidence of adverse events (AEs), including treatment-emergent AEs (TEAEs), AEs of special interests (AESIs), AEs leading to discontinuation and serious AEs (SAEs) through the study.
Detailed description
• Absolute and percent change in EASI score from baseline at each visit up to Week 16 and up to Week 52 • Proportion of subjects achieving 50%, 75% or 90% response in EASI [EASI-50, EASI-75, and EASI-90] at baseline and at each visit up to Week 16 and Week 52 • IGA success rate (defined as an IGA of 0 [Clear] or 1 [Almost clear] and a ≥2-point improvement from baseline) at each visit up to Week 16 and up to Week 52
Interventions
DRUGNemolizumab
Sponsors
Galderma S.A.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Nemolizumab serum concentrations at Weeks 4, 8, 12, 16, 32, and 52. • Nemolizumab serum PK parameters estimated with a population PK analysis., • Incidence of adverse events (AEs), including treatment-emergent AEs (TEAEs), AEs of special interests (AESIs), AEs leading to discontinuation and serious AEs (SAEs) through the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Absolute and percent change in EASI score from baseline at each visit up to Week 16 and up to Week 52 • Proportion of subjects achieving 50%, 75% or 90% response in EASI [EASI-50, EASI-75, and EASI-90] at baseline and at each visit up to Week 16 and Week 52 • IGA success rate (defined as an IGA of 0 [Clear] or 1 [Almost clear] and a ≥2-point improvement from baseline) at each visit up to Week 16 and up to Week 52 | — |
Countries
Hungary, Poland, Spain
Outcome results
None listed